MONTPELLIER, FRANCE — Sensorion has received authorization from France’s National Agency for Medicines and Health Products Safety (ANSM) to begin a Phase I/II clinical trial of SENS-601, its investigational gene therapy targeting GJB2-related hearing loss.
The authorization, granted August 31 through ANSM’s Fast Track assessment process, clears the company to initiate the HearConnex clinical trial in France. Site start-up activities are now underway, with Sensorion targeting dosing of the first patient by early 2027.
Clinical data from the study are expected to be generated throughout 2027.
The regulatory clearance represents the latest step in Sensorion’s development of SENS-601 as its lead gene therapy program for GJB2-related hearing loss. Earlier this year, the company submitted Clinical Trial Applications in France and Canada as it shifted development resources toward the program and away from SENS-501, its previous gene therapy candidate for OTOF-related hearing loss.
HearConnex Phase I/II Trial
HearConnex is designed as a two-part, open-label study evaluating SENS-601 in children with congenital DFNB1A hearing loss associated with GJB2 mutations.
In the first part of the trial, researchers will evaluate the safety and tolerability of SENS-601 following unilateral intra-cochlear administration across two ascending-dose cohorts.
The second portion will evaluate efficacy in an expansion cohort using bilateral intra-cochlear administration at the selected dose. Researchers will also assess the safety, tolerability, performance and usability of Sensorion’s injection system.
Professor Natalie Loundon, M.D., Director of the Center for Research in Pediatric Audiology and Pediatric Otolaryngologist and Head and Neck Surgeon at Necker Enfants Malades, AP-HP, will serve as Principal Investigator for the French portion of HearConnex.
“Children born with GJB2-related hearing loss, and their families, hope for additional therapeutic options that address the underlying cause of the condition. Bringing gene therapy into the clinic for this population requires a highly specialized surgical and audiological environment, and the teams involved have built this experience over the years notably through the course of our Audiogene clinical trial.”
Dr. Sharon Cushing, Pediatric Otolaryngologist and Director of the Cochlear Implant Program at The Hospital for Sick Children (SickKids) in Toronto, will serve as Coordinating Investigator for the multi-regional HearConnex study.
Targeting a Common Cause of Genetic Hearing Loss
SENS-601 (GJB2-GT) is an investigational AAV-based gene therapy developed in collaboration with Professor Christine Petit’s team at Institut Pasteur–Institut de l’Audition/Institut reConnect.
The therapy is designed to address hearing loss caused by mutations in the GJB2 gene, which plays an important role in maintaining the ionic balance required for sound transduction within the inner ear.
GJB2 mutations are among the most common causes of genetic congenital deafness and are estimated to account for approximately 50% of autosomal recessive non-syndromic hearing loss. There is currently no approved gene therapy addressing GJB2-related hearing loss.
Sensorion said the clinical program is supported by preclinical studies demonstrating significant hearing restoration following SENS-601 administration in clinically relevant animal models developed by Professor Petit’s laboratory, along with toxicology, activity and manufacturing studies completed in preparation for human testing.
“Securing approval to initiate HearConnex marks a significant milestone for Sensorion and, above all, for the children and families affected by congenital DFNB1A hearing loss, for whom no treatment addressing the underlying biological cause of the disease exists today.”
— Fred Chereau, Chief Executive Officer of Sensorion
Additional Regulatory Submissions Planned
HearConnex is intended to become a multi-regional clinical trial. Sensorion said Health Canada’s review of its Clinical Trial Application, submitted in June, remains underway.
The company is also targeting submission of a Clinical Trial Application in Australia and an Investigational New Drug (IND) application in the United States by the end of 2026.
Sensorion plans to provide additional details about SENS-601 and the HearConnex trial during an online SENS-601 Program Day on September 22, 2026. The event is expected to cover the underlying science, target patient population, trial design and clinical endpoints, with presentations from Professor Christine Petit, Dr. Sharon Cushing and members of Sensorion’s management team.
Source: Sensorion
